A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate

Pfizer

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tofacitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02147587

2014-000706-34 (EudraCT Number)

A3921237

Details and patient eligibility

About

This study will evaluate immune response following administration of zoster vaccine in subjects with rheumatoid arthritis who are receiving background methotrexate and initiate 5 mg twice daily of tofacitinib or placebo for tofacitinib 2 to 3 weeks following vaccination.

Enrollment: 112 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have moderate to severe rheumatoid arthritis inadequately controlled by methotrexate as defined by the American College of Rheumatology (ACR) classification criteria for Rheumatoid arthritis, painful and swollen joint counts and C-reactive protein (CRP).
• Screening CRP >3 mg/L or CDAI score > 10 at screening or at baseline before vaccination.
• Subjects must have active disease at screening and baseline.
• Must be at least 50 years of age or older.

Exclusion criteria

• History of receiving any varicella-zoster virus vaccine
• Receipt of any vaccines within 6 weeks of first dose of study treatment.
• Subjects with current infections or history of infections.
• History of recurrent (more than one episode) of herpes zoster or disseminated (a single episode) of herpes zoster or disseminated (a single episode) of herpes simplex.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups, including a placebo group

Tofacitinib 5 mg BID (oral) (70 subjects)

Experimental group

Description:

Zoster vaccine will be administered to subjects on background methotrexate; treatment with 5 mg tofacitinib twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.

Treatment:

Drug: Tofacitinib

Placebo tofacitinib BID (oral) (70 subjects)

Placebo Comparator group

Description:

Zoster vaccine will be administered to subjects on background methotrexate; treatment with placebo twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.

Treatment:

Drug: Placebo